Registration Dossier
Registration Dossier
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EC number: 245-018-1 | CAS number: 22464-99-9
Carcinogenicity
Administrative data
Description of key information
Key value for chemical safety assessment
Justification for classification or non-classification
2-ethylhexanoic acid, zirconium salt is not expected to be carcinogenic, since the two constituents zirconium and 2-ethylhexanoic acid are also not classified as carcinogenic. Thus, 2-ethylhexanoic acid, zirconium salt is not classified according to regulation (EC) 1272/2008 as carcinogenic.
Additional information
Read-across approach
Selected endpoints for the human health hazard assessment are addressed by read-across, using a combination of data on the metal cation and the organic acid anion. This way forward is acceptable, since metal carboxylates are shown to dissociate to the organic anion and the metal cation upon dissolution in aqueous media. No indications of complexation or masking of the metal ion through the organic acid were apparent during the water solubility and dissociation tests (please refer to the water solubility and dissociation in sections 4.8 and 4.21 of IUCLID). Once the individual transformation products of the metal carboxylate become bioavailable (i.e. in the acidic environment in the gastric passage or after phagocytosis by pulmonary macrophages), the “overall” toxicity of the dissociated metal carboxylate can be described by a combination of the toxicity of these transformation products, i.e. the metal cation and carboxylate anion according to an additivity approach.
2-ethylhexanoic, zirconium salt is the zirconium metal salt of 2-ethylhexanoic acid, which readily dissociates to the corresponding zirconium cation and 2-ethylhexanoate anions. The zirconium cation and the 2-ethylhexanoate anion are considered to represent the overall toxicity of 2-ethylhexanoic, zirconium salt in a manner proportionate to the free acid and the metal (represented by one of its readily soluble salts).
A detailed justification for the read-across approach is added as a separate document in section 13 of IUCLID.
Carcinogenicity
No carcinogenicity study with 2-ethylhexanoic acid, zirconium salt is available, thus the carcinogenicity will be addressed with existing data on the dissociation products as detailed in the table below.
Table: Summary of carcinogenicity data of 2-ethylhexanoic acid, zirconium salt and the individual constituents.
| Zirconium | 2-ethylhexanoic acid (CAS# 149-57-5) | 2-ethylhexanoic, zirconium salt |
Carcinogenicity | Negative | Negative | Negative |
Zirconium
No carcinogenicity data available. Nevertheless from the data available on zirconium dioxide, testing is not required as zirconium dioxide is not mutagenic and no evidence of hyperplasia or pre-neoplastic lesions is observed from the repeated dose studies.
2-ethylhexanoic acid
2-ethylhexanoic acid is not mutagenic in the Ames test or in mammalian cell systems both in the absence and presence of metabolic activation. 2-ethylhexanoic acid did not induce micronuclei in bone marrow of mice. Taking into account the lack of genotoxic effects, it is concluded that carcinogenicity should not be an endpoint of concern.
2-ethylhexanoic acid, zirconium salt
2-ethylhexanoic acid, zirconium salt is not expected to be carcinogenic, since the two constituents zirconium and 2-ethylhexanoic acid have not shown carcinogenic properties. Thus, 2-ethylhexanoic acid, zirconium salt is not classified according to regulation (EC) 1272/2008 as carcinogen. Further testing is not required. For further information on the toxicity of the individual constituents, please refer to the relevant sections in the IUCLID and CSR.
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